Steffan Jean, Parks Craig, Seewald Wolfgang
Novartis Animal Health, CH4002 Basel, Switzerland.
J Am Vet Med Assoc. 2005 Jun 1;226(11):1855-63. doi: 10.2460/javma.2005.226.1855.
To determine efficacy and safety of cyclosporine in the treatment of atopic dermatitis among dogs in North America.
Randomized controlled (phase 1) and open-label (phase 2) trials.
268 dogs with atopic dermatitis.
In phase 1, dogs were randomly assigned to be treated with cyclosporine (5 mg/kg [2.3 mg/Ib], PO, q 24 h) or a placebo. In phase 2, all dogs were treated with cyclosporine for 16 weeks. Frequency of cyclosporine administration was decreased if dogs improved clinically.
At the end of phase 1, canine atopic dermatitis extent and severity index (CADESI) scores for dogs treated with cyclosporine were significantly lower than scores for control dogs. Percentage of dogs with severe pruritus decreased from 67% to 16% for the cyclosporine group but from 66% to only 61% for the control group. During phase 2, cyclosporine dosage was decreased to every-other-day administration in 39% of the dogs after 4 weeks. After 12 weeks, 22% of the dogs were treated twice weekly and 36% were treated every other day. After 16 weeks, CADESI score had decreased > 50% in 68% of the dogs and 47% of dogs had no or mild pruritus. The most frequent adverse reactions were gastrointestinal tract signs.
Results suggest that cyclosporine is efficacious for the treatment of atopic dermatitis in dogs and that frequency of cyclosporine administration can be reduced following an initial induction period. The drug was well tolerated.
确定环孢素治疗北美犬特应性皮炎的疗效和安全性。
随机对照（1期）和开放标签（2期）试验。
268只患有特应性皮炎的犬。
在1期，犬被随机分配接受环孢素（5mg/kg[2.3mg/磅]，口服，每24小时一次）或安慰剂治疗。在2期，所有犬接受环孢素治疗16周。如果犬临床症状改善，环孢素给药频率降低。
在1期结束时，接受环孢素治疗的犬的犬特应性皮炎范围和严重程度指数（CADESI）评分显著低于对照犬。环孢素组严重瘙痒犬的百分比从67%降至16%，而对照组从66%仅降至61%。在2期，4周后39%的犬环孢素剂量减为隔日给药。12周后，22%的犬每周治疗两次，36%的犬隔日治疗。16周后，68%的犬CADESI评分降低>50%，47%的犬无瘙痒或轻度瘙痒。最常见的不良反应是胃肠道症状。
结果表明环孢素对犬特应性皮炎有效，且在初始诱导期后环孢素给药频率可降低。该药物耐受性良好。
